MAUDE Adverse Event Report: THERAKOS XTS PHOTOPHERESIS SYSTEM

Model Number	NOT APPLICABLE
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction centrifuge bowl leak/break.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.Kit lot f705 was reviewed.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot f705 identified an increase in complaints associated with the centrifuge bowl leak/break complaint category.An investigation has been initiated in response to the increase of centrifuge bowl leak/break complaints observed with kit lot f705.Trends were reviewed for complaint categories, leak centrifuge alarm, centrifuge bowl leak/break.No trends were detected for each complaint category.The assessment is based on the information available at the time of investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Investigation complete.(b)(4).
Event or Problem Description
Customer called to report a centrifuge bowl leak that occurred during a patient treatment.The customer stated that prior to the centrifuge bowl leak/ break a leak centrifuge alarm occurred in cycle 4 during the final buffy coat collection.The customer said they then noticed a slight spray of blood in the centrifuge chamber.The customer aborted the procedure with no blood returned back to the patient.The patient was said to be in stable condition and asymptomatic.The customer will not be returning any products back for investigation.

• Brand Name: XTS PHOTOPHERESIS SYSTEM
• Common Device Name: XTS PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• MDR Report Key: 7249649
• Report Number: 2523595-2018-00034
• Device Sequence Number: 1223478
• Product Code: LNR
• UDI-Device Identifier: 20705030200027
• UDI-Public: (01)20705030200027(10)F705(17)220301
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P860003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Expiration Date: 03/01/2022
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: XT125
• Device Lot Number: F705
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2017
• Initial Report FDA Received Date: 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 54